Why it was recalled
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Product description
Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90
Lot numbers, UPCs & expiration codes
Lot #: STBG005, Exp 2/2015
Where it was sold
NY
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0246-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 19, 2014
- FDA report date
- Nov 19, 2014
- Quantity
- 1,008 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Micro Labs Usa, Inc S
Original FDA data
Every field from FDA enforcement report D-0246-2015, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 69268
- Address
- 104 Carnegie Ctr
- Address (line 2)
- Te 216
- Code information
- Lot #: STBG005, Exp 2/2015
- Postal code
- 08540-6232
- Report date
- Nov 19, 2014
- Product type
- Drugs
- Recall number
- D-0246-2015
- Classification
- Class III
- Recalling firm
- Micro Labs Usa, Inc S
- Product quantity
- 1,008 bottles
- Termination date
- Apr 19, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90
- Distribution pattern
- NY
- Recall initiation date
- Aug 19, 2014
- Initial firm notification
- Letter
- Center classification date
- Nov 12, 2014